NCT05442645已完成不适用
Observational Study of Atopic Dermatitis Patients Treated With Dupilumab in Taiwan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations
研究概览
简要总结
Primary objective:
To characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult AD patients, who are eligible for dupilumab reimbursement in Taiwan (e.g., used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching).
Secondary objectives:
- To characterize the adult AD patients, who are eligible for dupilumab reimbursement in Taiwan, with respect to their a) medical history, b) socio-demographic, c) disease characteristics, d) comorbid with type 2 diseases [e.g., Asthma, Chronic rhinosinusitis with nasal polyp (CRSwNP)], and e) prior and concomitant treatments of atopic dermatitis
- To assess the effectiveness and safety of dupilumab in adult atopic dermatitis patients, who are eligible for dupilumab reimbursement in Taiwan
- To assess comorbid atopic conditions and effects of dupilumab treatment for comorbid atopic conditions in adult patients, who are eligible for dupilumab reimbursement in Taiwan
- To evaluate the correlation of patient reported outcome [Atopic Dermatitis Control Tool (ADCT)] and physician assessment [Eczema Area and Severity Index (EASI)] from the recruited subjects
详细描述
1 year
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years or older at the baseline visit
- •Initiating treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information
- •Note: Patients, who are diagnosed with AD more than 6 months, Eczema Area and Severity Index (EASI) more than or equals to
- •body surface area (of AD involvement) (BSA) more than or equals to 30% and IGA=3-4, may be eligible if they have already initiated treatment with:
- •Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B (nb-UVB) twice a week) more than 3 months, and,
- •Two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more than 3 months respectively before their enrollment in the registry.
- •Provided signed informed consent
排除标准
- •Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments
- •Patients currently participating in any interventional clinical trial which modifies patient care
- •Patients who have a contraindication to dupilumab according to the country-specific prescribing information
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations
时间窗: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens
时间窗: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reason for initiation of new treatments
时间窗: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reasons for discontinuation and/or switching
时间窗: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Concomitant therapies
时间窗: At baseline (Day 1)
次要结局
- Characterization of real-world use patterns of dupilumab for AD: Concomitant therapies taken for AD(Up to 12 months)
- Effectiveness of dupilumab: change from baseline in Eczema Area and Severity Index (EASI)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in body surface area (of AD involvement) (BSA)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in Investigator global assessment scale (IGA)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in Scoring of Atopic Dermatitis (SCORAD)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in Pruritus Numerical Rating Scale (NRS)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in Sleep NRS(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in Patient-Oriented Eczema Measure (POEM)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in Atopic Dermatitis Control Tools (ADCT)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab: change from baseline in Dermatology Life Quality Index (DLQI)(Day 0, Months 3, 6, 9 and 12)
- Effectiveness of dupilumab in relevant comorbid conditions: change in Juniper Asthma Control Questionnaire (ACQ-5) from the first reported time point of Asthma(Day 0 to Month 12)
- Effectiveness of dupilumab in relevant comorbid conditions: change in 22-item Sino-Nasal Outcome Test (SNOT-22) from the first reported time point of Asthma(Day 0 to Month 12)
- Percentage of participants reporting that their comorbid condition got better, and the percentage reporting their condition got worse at each follow-up visit by each specific condition (other than asthma and allergic rhinitis)(Day 0 to Month 12)
- Characterization of the patients who receive dupilumab for AD: Medical history(At baseline (Day 1))
- Characterization of the patients who receive dupilumab for AD: Socio-demographic data(At baseline (Day 1))
- Characterization of the patients who receive dupilumab for AD: Prior and concomitant treatments of AD; percentage who were on dupilumab at the baseline/enrollment visit (Visit 1)(At baseline (Day 1))
- Characterization of the patients who receive dupilumab for AD: Reason for initiation of dupilumab(At baseline (Day 1))
- Safety: Number of patients with at least 1 adverse event (AE)(Day 0 to Month 12)
- Safety: Annualized event rates of AEs(Day 0 to Month 12)
- Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (Asthma Control Questionnaire (ACQ-5))(At baseline (Day 1))
- Characterization of real-world use patterns of dupilumab for AD: Longest duration of use(Up to 12 months)
- Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (22-item Sino-Nasal Outcome Test (SNOT-22))(At baseline (Day 1))
- Characterization of real-world use patterns of dupilumab for AD: Dupilumab dose regimens used over the study, and the duration with each regimen(Up to 12 months)
- Characterization of real-world use patterns of dupilumab for AD: Percent discontinuing dupilumab, including temporary or permanent discontinuation; reasons for discontinuation(Up to 12 months)
- Characterization of real-world use patterns of dupilumab for AD: Percentage of patients whose dose (either the frequency of the strength) increased from starting regimen and reasons; percentage whose dose decreased from the starting regimen and reasons(Up to 12 months)
- Characterization of real-world use patterns of dupilumab for AD: Number of gaps in dupilumab treatment and longest gap length(Up to 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)Dermatitis, AtopicNCT03428646Regeneron Pharmaceuticals858
已完成
不适用
Medium-Dose UVA1 Versus Narrow-Band UVB in Atopic DermatitisAtopic DermatitisNCT00419406Ruhr University of Bochum28
Unknown
不适用
Atopic Dermatitis: Early Gene Expression Changes as Predictors of Therapeutic Response to Narrow-band UVB TreatmentAtopic DermatitisNCT03402412Oslo University Hospital16
招募中
不适用
Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab TreatmentAtopic DermatitisNCT04276623UMC Utrecht150
终止
不适用
Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic DermatitisAtopic DermatitisNCT00931411Cosmetique Active International73